CN115708843A - Qi-tonifying, blood-activating and detoxifying formula and application thereof - Google Patents
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Abstract
The invention belongs to the field of traditional Chinese medicines, and particularly relates to a qi-tonifying, blood-activating and detoxifying formula and application thereof, wherein the main active ingredients comprise the following components in parts by mass: 10 to 30 parts of sun-dried ginseng, 6 to 30 parts of pseudo-ginseng and 3 to 15 parts of rhubarb. Clinical tests show that the qi-tonifying, blood-activating and detoxifying prescription can reduce the APACHE II score of a patient with secondary sepsis caused by pulmonary infection and improve the condition of the patient; meanwhile, the medicine has the definite function of reducing the white blood cell count and the neutrophil count of the patient, and reduces the inflammatory reaction of the patient. Subgroup analysis finds that the formula for tonifying qi, activating blood and detoxifying shows a definite effect of improving oxygenation of a patient on mechanical ventilation, and shows that the formula can improve oxygenation of the patient to a certain extent through the bowel relaxing effect and the anti-inflammatory effect of the formula, so that the formula can play a role in shortening mechanical ventilation time of the patient.
Description
Technical Field
The invention belongs to the field of traditional Chinese medicines, and particularly relates to a qi-tonifying, blood-activating and detoxifying formula and application thereof.
Background
Sepsis (Sepsis) refers to a life-threatening Organ dysfunction caused by a disregulated host response due to infection, with exacerbations that can lead to septic shock, and is a significant cause of Multiple Organ Failure (MOF) and even death. Statistically, about 1400 people die of sepsis every day worldwide, with a mortality rate of about 20%. Studies in critically ill patients have shown a sepsis incidence of 15.7%, with 61.1% of these further progressing to Multiple Organ Dysfunction Syndrome (MODS) and a mortality rate of 30.6%. The death from sepsis is an absolute rising trend, and it has become one of the main causes of death in patients with clinical critical illness.
International guidelines for the treatment of sepsis and septic shock in 2016 recommend mechanical ventilation for the treatment of sepsis. Research shows that the pulmonary alveolus collapse and the lung volume reduction can be effectively improved by adopting the high-expiratory positive-pressure lung re-tensioning after the sputum aspiration of patients with the septic shock, and the hemodynamic indexes and the respiratory mechanical indexes can be improved.
Dexmedetomidine is the hot spot of current research for the sedation treatment of mechanical ventilation in septic patients, but its clinical efficacy remains controversial. A study involving 201 patients did not reveal significant effects of dexmedetomidine on mortality and non-mechanical ventilation time (see Kawazoe Y, miyamoto K, et al. Effect of dexmedetomidine on mortality and ventilator-free days in tissues requiriing mechanical ventilation with syndrome a random clinical trial [ J ]. JAMA,2017, 317 (13): 1321-1328.). In addition, dexmedetomidine is used to treat sepsis which may cause adverse reactions such as hypotension, bradycardia, sinus arrest, transient hypertension, etc.
The traditional Chinese medicine is developed based on syndrome differentiation and has unique advantages in the treatment of sepsis. Although the guidelines for treating sepsis by traditional Chinese medicine are not recommended, traditional Chinese medicine is used as a treatment means to assist western medicine treatment, and plays an increasingly important role in the treatment of sepsis. Therefore, there is an urgent need to develop a safe and effective Chinese medicinal composition for treating sepsis, which can be used for assisting the treatment of sepsis.
Disclosure of Invention
The first purpose of the invention is to provide a qi-tonifying, blood-activating and detoxifying formula, and the second purpose of the invention is to provide application of the qi-tonifying, blood-activating and detoxifying formula.
According to the first aspect of the invention, the invention provides a qi-tonifying, blood-activating and detoxifying formula, which comprises the following main active ingredients in parts by mass: 10 to 30 parts of sun-dried ginseng, 6 to 30 parts of pseudo-ginseng and 3 to 15 parts of rhubarb.
The invention considers that the sepsis belongs to the warm-heat disease, or is caused by the deficiency and the evil, or is serious because the evil and the poison damage the vital qi, and is easily shown as the large damage of the original qi and the deficiency of the visceral qi. The sun-dried ginseng is sweet and slightly cold in taste, mainly tonifies five internal organs, is neutral in nature and taste, is comprehensive in tonifying, and is suitable for the characteristics that sepsis is easy to damage five internal organs and primordial qi. Therefore, the invention takes the sun-dried ginseng as the monarch drug.
In the formula, the sun-dried ginseng is used for tonifying primordial qi as a monarch drug; the pseudo-ginseng has the effects of promoting blood circulation to remove blood stasis, and the rhubarb has the effects of clearing heat and removing toxicity, and the pseudo-ginseng and the rhubarb are used as ministerial drugs; da Huang Tongfu purgation is used as adjuvant drug, while Da Huang Tong twelve meridians are used as guiding drug. The whole formula has the effects of tonifying qi, activating blood circulation and detoxifying.
The raw materials of the formula are as follows:
sun-dried ginseng: dried root of Panax ginseng C.A.Mey. Belonging to Araliaceae family is named as "Yuanshen", which is sun-dried or oven-dried, and is called "sun-dried Ginseng". It enters spleen, lung and heart meridians. Sweet, slightly bitter and neutral.
Pseudo-ginseng: dried root of Panax notoginseng (Burk.) F.H.Chen of Araliaceae family. Sweet, slightly bitter and warm. It enters liver and stomach meridians.
Rhubarb: dried roots and rhizomes of Rheum palmatum L., rheum officinale (Rheum officinale L.), rheum officinale of Rheum officinale Baill., rheum tanguticum Maxim. Ex Balf.). Bitter taste and cold nature. It enters spleen, stomach, large intestine, liver and pericardium meridians.
In some embodiments, the main active ingredients thereof comprise, in parts by mass: 30 parts of sun-dried ginseng, 30 parts of pseudo-ginseng and 5 parts of rhubarb.
In some embodiments, a medically acceptable excipient is also included. Specifically, the excipients used are carriers or excipients commonly used in the art, including but not limited to starch, lactose, glucose, sodium carboxymethylcellulose, ethyl cellulose and methyl cellulose, malt, gelatin, polyols (such as propylene glycol, glycerol, mannitol), tableting agents and the like to help improve the stability or activity of the drug or to produce an acceptable mouth feel or odor in the case of oral administration.
In some embodiments, the formulation of the qi-tonifying, blood-activating and detoxifying formulation is decoction, granule, powder, tablet, pill or capsule. Thereby facilitating clinical administration.
According to a second aspect of the invention, the application of the qi-tonifying, blood-activating and detoxifying method in preparing a medicament for treating sepsis is provided.
According to the third aspect of the invention, the application of the qi-tonifying, blood-activating and detoxifying formula in preparing the medicine for treating the sepsis secondary to the lung infection is provided.
According to a fourth aspect of the invention, there is provided the use of a qi-replenishing, blood circulation-activating and detoxifying formulation as defined above in the manufacture of a medicament for reducing the APACHE II score and/or improving the oxygenation index (PaO 2/FiO 2) in sepsis patients secondary to a pulmonary infection.
The beneficial effects of the invention include:
clinical tests show that the qi-tonifying, blood-activating and detoxifying prescription can reduce the APACHE II score of a patient with secondary sepsis caused by pulmonary infection and improve the condition of the patient; meanwhile, the medicine has the definite function of reducing the white blood cell count and the neutrophil count of the patient, and reduces the inflammatory reaction of the patient. Subgroup analysis finds that the formula for tonifying qi, activating blood and detoxifying shows a definite effect of improving oxygenation of a patient on mechanical ventilation, and shows that the formula can improve oxygenation of the patient to a certain extent through the bowel relaxing effect and the anti-inflammatory effect of the formula, so that the formula can play a role in shortening mechanical ventilation time of the patient.
Drawings
FIG. 1 is a flow chart of screening and inclusion in subjects in a clinical trial of the invention.
Fig. 2 is the trend of the severe score and the peripheral blood neutrophil count over the treatment time for two groups of patients in the clinical trial of the present invention, wherein fig. 2 (a) is the trend of the severe score over the treatment time for two groups of patients in the clinical trial of the present invention, fig. 2 (b) is the trend of the peripheral blood neutrophil count over the treatment time for two groups of patients in the clinical trial of the present invention, in which a: control group, test group B.
Fig. 3 is a graph of the trend of the oxygenation index of the mechanical ventilation subgroup over the treatment time in a clinical trial of the invention, in which a: control group, test group B.
Detailed Description
The present invention will be described in further detail with reference to specific examples. The raw materials used in the present invention are all commercially available unless otherwise specified.
Example 1
The qi-tonifying, blood-activating and detoxifying formula granule is prepared from the following components: 30g of sun-dried ginseng, 30g of pseudo-ginseng and 5g of rhubarb.
Illustratively, the preparation method comprises the following steps:
(1) Extraction:
first decocting: adding Notoginseng radix and Ginseng radix decoction pieces, adding 10 times of water, heating to boil, maintaining slightly boiling for 1 hr, and vacuum filtering (200 mesh);
decocting for the second time: adding radix et rhizoma Rhei decoction pieces, adding 6 times of water, heating to boil, maintaining slightly boiling for 0.5 hr, and vacuum filtering (200 mesh);
decocting for three times: adding 6 times of water, heating to boil, keeping slightly boiling for 0.5 h, and performing suction filtration (200 meshes);
(2) Concentration: concentrating the filtrate under reduced pressure to obtain fluid extract with certain specific gravity;
(3) Spray drying: spray drying the obtained clear paste, and setting the process parameters as follows: collecting powder at air inlet temperature of 165-195 deg.C and air outlet temperature of 80-105 deg.C to obtain dry extract powder;
(4) Sieving and mixing: sieving the obtained dry extract powder, and mixing for 30 minutes to obtain an extracted intermediate;
(5) And (3) granulating: and granulating the extracted intermediate by a dry method to prepare granules of 12-40 meshes.
The amount of rhubarb in the qi-tonifying, blood-activating and detoxifying prescription can be increased or decreased according to circumstances, and in order to facilitate the increase or decrease of the amount of rhubarb in the granules of the qi-tonifying, blood-activating and detoxifying prescription of the embodiment, rhubarb granules are also prepared, and the preparation method comprises the following steps:
and taking 10g of rhubarb, preparing the rhubarb extract according to the conventional method in the field, and then granulating the rhubarb extract by adopting a dry method to prepare granules of 12-40 meshes.
After the granules are prepared, the qi-tonifying, blood-activating and detoxifying prescription granules with the net weight of 5.1g and the rheum officinale granules with the net weight of 0.8g are respectively packaged into small aluminum foil bags, so that the clinical administration is convenient.
Next, in order to investigate the influence of the qi-tonifying, blood-activating and detoxifying prescription of the present invention on the immune function and clinical prognosis of patients with secondary sepsis in lung infection, the following clinical tests were performed using the qi-tonifying, blood-activating and detoxifying prescription granule and rhubarb granule prepared in example 1.
1. Source of case
Patients with secondary sepsis caused by pulmonary infection who are hospitalized in ICU of an emergency department in a certain hospital in Guangdong province in 11-2021 in 2020 for 10 months.
Inclusion criteria were: compliance with the Sepsis3.0 diagnostic standard set in the 2016 SSC guidelines; the diagnosis standard of lung infection is met, and the infection source of the sepsis is considered as lung infection; age 18-85 years old; signing the informed consenter.
Exclusion criteria: possible deaths within 24 hours; patients with severe disease requiring cardiopulmonary resuscitation; malignant tumor in late stage with dyscrasia; patients with acute coronary artery disease, such as acute myocardial infarction; for those with drug allergy or allergic constitution in the qi-tonifying, blood-activating and detoxifying formula; a pregnant woman; other clinical experimenters participated in the last 3 months; clinical researchers believe there are other situations that are not suitable for participation in the study.
Shedding and rejecting standard: (1) finding out the patients who do not meet the inclusion and exclusion standards in the later period; (2) after the composition is used in a group, the pedicure Cheng Yiqi formula for activating blood and removing toxicity is not taken, and the curative effect of the composition cannot be evaluated.
2. Random double-blind scheme
Patients were treated with the qi-tonifying, blood-activating and detoxifying formula randomly at a rate of 1:1 or placebo (package, color, granule properties consistent for placebo and qi-tonifying, blood-activating and detoxifying formula). All sequence numbers, random numbers, were managed by the clinical methodology research team. The blind method code is made after the randomization operation, the order number of the subject and the corresponding random number and grouping result (i.e. the subject is assigned to group A or B) are the first-level blind bottom; and blind two groups of medicines A, B, namely a secondary blind bottom (namely which group in A, B uses the traditional Chinese medicine or placebo), randomly numbering the medicines of each subject in sequence, and recording and properly storing all operation processes.
During the study, the investigator acquires the random number by sequence number via a random envelope. All the patients, researchers, statistical analysis personnel and other personnel participating in the research are unaware of the treatment scheme, first-level blindness removal, clear grouping and statistical analysis are carried out after the research is finished, second-level blindness removal is carried out after a clinical research methodology team issues a statistical analysis report, and a treatment group and a control group are clear.
3. Intervention
Test groups: on the basis of the Western medicine intervention scheme of 2016Sepsis3.0 guideline, the qi invigorating, blood circulation promoting, and toxic substance removing granule and radix et rhizoma Rhei granule prepared in example 1 are added simultaneously (2 times daily, each time 1 bag of qi invigorating, blood circulation promoting, and toxic substance removing granule and 2 bags of radix et rhizoma Rhei granule are dissolved in 50mL warm water and then taken orally/fed nasally; treatment course: 7 days).
Control group: on the basis of the 2016Sepsis3.0 guideline Western medicine intervention scheme, placebo for qi-tonifying, blood-activating and detoxifying prescription and granules for Huang Anwei (2 times a day, 1 bag of placebo for qi-tonifying, blood-activating and detoxifying prescription and 2 bags of Huang Anwei for each time, 50mL warm water is dissolved and then the mixture is orally taken/nasal fed, and the treatment course is 7 days).
Dosage of radix et rhizoma Rhei granule and placebo is increased or decreased according to patient stool condition, such as stool decay and stool time more than 3 times/day.
The placebo for the qi-tonifying, blood-activating and detoxifying prescription consists of maltodextrin, lemon yellow, sunset yellow, caramel pigment and bittering agent (which are all food grade), and the appearance, taste, weight and the like of the placebo are consistent with those of the qi-tonifying, blood-activating and detoxifying prescription granules.
The rhubarb placebo consists of maltodextrin, lemon yellow, sunset yellow, caramel color, bittering agent (all food grade), and the appearance, taste, weight, etc. of the rhubarb placebo are consistent with those of rhubarb granules.
The qi-tonifying, blood-activating and detoxifying granule and the placebo are both produced by Jiangyin pharmaceutical Limited.
4. Evaluation index
The ending index: mortality in 28 days; 7 days mortality; the number of hospitalization days; mechanical ventilation time; SOFA score: time points 1d, 3d, 7d; APACHE ii score: time points 1d, 3d, 7d; immune-inflammation and organ function related laboratory indices: WBC, PCT, CRP, LAC, T lymphocyte subpopulation (CD 4+, CD8+, CD4+/CD8 +), oxygenation index (PaO 2/FiO 2), PLT, TBIL, cr: time points 1d, 3d, 7d.
Safety evaluation index: various drug allergies (including rashes), gastrointestinal reactions (including nausea, vomiting, diarrhea), psychiatric disorders (insomnia, headache, dizziness) and laboratory examinations for abnormal changes were observed and reported in detail. Monitoring the occurrence condition of adverse events: reporting serious adverse events in time; all adverse events were evaluated for association with study drug.
5. Statistical analysis
Evaluation of balance between baseline groups: for quantitative data which obey normal distribution, mean +/-standard deviation representation is adopted, and t test is adopted for comparison of two groups; for quantitative data which do not conform to normal distribution, the quantitative data are expressed by using median (quartile), and the comparison of two groups adopts Man-Whitney U test; for qualitative data, frequency and rate representation is adopted, and the comparison among groups adopts chi-square test or fisher exact probability method. The outcome index is analyzed by intention test (ITT), and the group of the subject is the group corresponding to the randomized distribution. Filling up missing values of the inspection results by adopting multiple filling (MI); the fatality rate of the outcome index for 28 days is compared and checked by chi-square; for a single point ending index, adopting t test for quantitative data which obeys normal distribution, or adopting Man-Whitney U test or chi-square test; for multiple measurements of the immune inflammation index, the single time point group-to-group comparison adopts covariance analysis, and the multiple time point group-to-group comparison adopts mixed effect model analysis.
The study is a multi-center pre-test, the number of test centers is3, and the number of samples in each center is small, so that the influence of center effects on the curative effect index is not considered. All tests were performed in a two-sided test, with P <0.05 as the difference being statistically significant.
6. Test results
1. Case shedding vs baseline
A total of 60 subjects were included in this study. Among them 4 cases of secondary sepsis due to definitive diagnosis of non-pulmonary infection after perfect examination: sepsis caused by urinary tract obstruction, abdominal infection with intestinal perforation, sepsis 1 with severe laryngopharyngeal and mediastinal infections, and acute large-area cerebral infarction 1. In the drug intervention process, 8 subjects dropped due to incomplete drug intervention protocol: 7 cases were discharged from the hospital after the family signed up for treatment, and 1 case was the subject who died after the family signed up for treatment. In the follow-up visit after intervention, 8 subjects died or were discharged from hospital due to family conservative treatment, and were scored as falling. See figure 1 for details.
Final 40 subjects completed the study, with 33 males (82.5%), 7 females (17.5%); the average age was 66.83 (+ -10.56) years, the minimum age was 32 years, the maximum age was 86 years, and 25 (62.5%) of the elderly patients aged 65 or older. Subjects died 0 within 7 days, 3 within 28 days, and 7.5% mortality at 28 days.
Through tests, the test group and the control group have no statistical difference in age, sex, basic diseases, SOFA score, APACHEII score, mechanical ventilation ratio and the like, and the control group has higher total bilirubin level in peripheral blood (16.2VS 7.9) and lower IL-6 level in peripheral blood (22.01VS 32.35) which are detailed in table 1.
TABLE 1 comparison of baseline demographics and clinical characteristics of two groups of subjects
2. Clinical prognosis
The statistical analysis shows that: the 28-day mortality rate of the patients in the test group was decreased (9.5% VS 5.26%) compared to the control group, and was not statistically significant. At day 7 of treatment, the test group had a lower APACHE II score (P < 0.05) (FIG. 2 (a)), with a lower trend for SOFA scores (P > 0.05). Total hospital stays (0 if patients are required for long-term hospitalization due to underlying disease) in the test group tended to be shorter (18.69 days VS 19.79 days), but were not statistically significant (P > 0.05). See table 2 for details.
TABLE 2 clinical prognostic comparison of two groups of subjects
| Index (I) | Control group (N = 21) | Test group (N = 19) | p |
| Death rate in 28 days | 9.5％ | 5.3％ | ＞0.99 |
| Day 7 SOFA score | 4.19 | 3.95 | 0.646 |
| Day 7 APACHEII score | 15 | 12.421 | 0.024 |
| Time of stay | 19.79 | 18.69 | 0.958 |
3. Immuno-inflammatory disorders
The analysis of variance and mixed effect model through repeated measurement of the immune-inflammatory indexes of the two groups shows that: on both days 3 and 7 after treatment, the peripheral blood neutrophil counts were lower in the test group of patients and the differences were statistically significant (P < 0.05) (FIG. 2 (b)). The test group had a lower tendency of peripheral blood leukocyte count and an elevated tendency of lymphocyte count than the control group. See table 3 for details.
TABLE 3 comparison of immune-inflammatory and hepatorenal function-related indices of two groups of subjects
4. Subgroup analysis
Subgroup analysis on patients who underwent mechanical ventilation found: compared with the control group, the oxygenation index of the test group patients is improved more obviously (P < 0.05) compared with the control group patients on the 3 rd day of treatment. See table 4 and figure 3 for details.
TABLE 4 mechanical ventilation subgroup oxygenation index comparison
| Index (I) | Control group (N = 14) | Test group (N = 15) | p |
| D3 oxygenation index (PaO 2/FiO 2) | 244.787 | 284.456 | 0.043 |
5. Safety feature
No adverse events and severe adverse events occurred throughout the study. Analysis of variance with repeated measurements of the liver and kidney function indices of two groups of patients found: the blood creatinine level, the total bilirubin level and the blood lactic acid level of two groups of patients have no statistical difference, and the safety of the qi-tonifying, blood-activating and detoxifying prescription is good. See table 5 for details.
TABLE 5 comparison of hepatic and renal function and blood lactate status of two groups of subjects
6. To summarize
On the whole, the qi-tonifying, blood-activating and detoxifying prescription can reduce the APACHE II score of a patient with secondary sepsis caused by lung infection and improve the condition of the patient; meanwhile, the medicine has the definite function of reducing the white blood cell count and the neutrophil count of the patient, and reduces the inflammatory reaction of the patient. Subgroup analysis finds that the qi-tonifying, blood-activating and detoxifying prescription has a definite effect of improving the oxygenation of a patient in mechanical ventilation, and shows that the prescription can improve the oxygenation of the patient to a certain extent through the bowel relaxing effect and the anti-inflammatory effect of the prescription, so that the prescription can play a role in shortening the mechanical ventilation time of the patient.
Claims (7)
1. The qi-tonifying, blood-activating and detoxifying formula is characterized by comprising the following main active ingredients in parts by mass: 10 to 30 parts of sun-dried ginseng, 6 to 30 parts of pseudo-ginseng and 3 to 15 parts of rhubarb.
2. The qi-tonifying, blood circulation-activating and detoxifying method as claimed in claim 1, wherein the main active ingredients comprise, in parts by mass: 30 parts of sun-dried ginseng, 30 parts of pseudo-ginseng and 5 parts of rhubarb.
3. The qi-tonifying, blood circulation-activating and detoxifying method according to claim 1 or 2, further comprising a pharmaceutically acceptable excipient.
4. The qi-replenishing, blood-activating and detoxifying prescription according to claim 1 or 2, wherein the formulation of the qi-replenishing, blood-activating and detoxifying prescription is decoction, granule, powder, tablet, pill or capsule.
5. Use of the qi-invigorating, blood-activating and detoxifying method according to any one of claims 1 to 4 in the preparation of a medicament for the treatment of sepsis.
6. Use of the qi-tonifying, blood-activating and detoxifying method according to any one of claims 1 to 4 in the preparation of a medicament for treating sepsis secondary to lung infection.
7. Use of the qi-invigorating, blood-activating and detoxifying formulation of any one of claims 1-4 in the manufacture of a medicament for reducing the APACHE II score and/or improving the oxygenation index in sepsis patients secondary to lung infection.
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Non-Patent Citations (1)
| Title |
|---|
| 林琳等: ""祛毒活血法结合西药治疗脓毒症的临床研究"", 《上海中医药杂志》, vol. 45, no. 6, pages 307 - 36 * |
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